BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1901896 · Received November 12, 2010

    Report

    Report Number
    1119421-2010-01267
    Event Type
    Injury
    Date Received
    November 12, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED ON 10/18/2010, 10/19/2010, AND 11/02/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED "A LOT" OF PATIENTS WHO DEVELOPED KERATITIS TWO TO THREE WEEKS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. HE REPORTED THAT ONE PATIENT (NO IDENTIFIERS) HAS "ONGOING ISSUES WITH UNRESOLVED SYMPTOMS." THE SURGEON REPORTED HE DOES NOT KNOW THE SOURCE BUT DOES NOT BLAME ANY OF THIS MANUFACTURER'S PRODUCTS USED IN THE SURGERIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE PATIENT WHO HAS "ONGOING ISSUES WITH UNRESOLVED SYMPTOMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BSS SOLUTION| CYSTITOMES| INFINITI SYSTEMS| CUSTOM PAKS| CANNULAS| IOLS (UNKNOWN MODELS)| BLADES| DISCOVISC| DUREZOL| CASSETTES